Environmentalists
Say Draft EPA Cancer Guidelines Must Be Broader To Protect Children
(from March 5, 2003)

EPA announced in the Federal Register on March 3, 2003 (68 FR 10012-10015)
the Draft
Final Guidelines for Carcinogen Risk Assessment and is asking for
public comment until May 1, 2003. According to the agency, "In
particular, the revisions to the Guidelines are intended to make greater
use of the increasing scientific understanding of the mechanisms that
underlie the carcinogenic process. EPA is especially interested in public
comments on the following areas: 1) use of default options; 2) hazard
descriptors; 3) mode of action; 4) extrapolation to lower doses; and
5) susceptible populations and lifestages. At the same time, EPA is
making available for public comment draft Supplemental Guidance describing
possible approaches that could be used to assess risks resulting from
early life exposure to potential carcinogens." At the same time,
EPA is making available for public comment draft Supplemental
Guidance describing possible approaches that could be used to assess
risks resulting from early life exposure to potential carcinogens.

The following is
taken from the EPA notice: In 1986, EPA
published a set of risk assessment guidelines, including Guidelines
for Carcinogen Risk Assessment. These Guidelines set forth principles
and procedures to guide EPA scientists in assessing the cancer risks
from chemicals or other agents in the environment and to inform the
public about these procedures. EPA continues to revise its risk assessment
guidelines and to develop new guidelines as experience and scientific
understanding evolve. EPA has designed its risk assessment guidelines
to be flexible enough to accommodate future scientific advances in science
and risk assessment practices. Because this current draft has already
benefited from extensive public comment and multiple rounds of expert
scientific review by EPA's Science Advisory Board (SAB), the Agency
is requesting that public comments focus on discussions of specific
science issues that are substantively revised or newly addressed since
the publication of the 1999 revised draft cancer guidelines.

As part of the revisions
process, the Agency published Proposed
Guidelines for Carcinogen Risk Assessment in 1996 (61 FR 17960,
Apr. 23, 1996). The draft revisions have been subject to extensive public
comment and scientific peer review, including three reviews by EPA's
Science Advisory Board. In 2001, EPA published a notice (66 FR 59593,
Nov. 29, 2001) providing an additional opportunity for public comment
on a 1999
draft of the Guidelines. Comments were invited on experience gained
in applying previous draft revised Guidelines and on specific issues
raised in previous comments by the SAB and the public.

Environmental Commentary

Environmentalists'
reaction to the draft is mixed. Advocates support the notion that children,
being more sensitive to toxic exposure than adults, require a special
analytical framework and extra precautionary standards. To the extent
that the guidelines recognize this, environmental advocates see this
as a step forward. However, EPA is proposing a standard that applies
a ten-fold extra margin of safety for children two years and under,
while it has been shown that in some cases chemicals may be as much
as 65 time more potent to children under the age of two. EPA data shows
that half of a person's lifetime cancer risk is experienced in the first
two years of life. Jane Houlihan, vice president of research for Environmental
Working Group, also cites that the guidelines focus on mutagenic (damage
to DNA) cancer risk, while there other mechanisms of cancer that must
be considered. Mutagenic carcinogens include arsenic, benzene, formaldehyde,
mutagen X, brominated organics and polycyclic aromatic hydrocarbons.
Because there are chemicals with other mechanisms than mutagenicity,
such as phthalates and atrazine, Houlihan says that the coverage of
the guidelines must be expanded.